MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number	07028091190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer questioned thyroid results for 1 patient sample tested on a cobas e 801 module.The sample was submitted for investigation where discrepant results were identified for elecsys tsh between the customer's e801 module and the siemens centaur method.Refer to attached data for the patient results.The initial results from the customer site were reported outside of the laboratory.There was no allegation that an adverse event occurred.The customer's e801 module serial number was (b)(4).The e801 module used at the investigation site was (b)(4).The tsh reagent lot number used at the investigation site was 283556 with an expiration date of feb-2019.Calibration and qc data from the customer site was not provided.From the data provided, a general reagent issue can be excluded.Assays from different manufacturers, in this case siemens can generate different results due to the overall setups of the assays, the antibodies used, and differences in reference materials and the standardization methodology used.The investigation was unable to find a definitive root cause.

• Brand Name: ELECSYS TSH ASSAY
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7794394
• Report Number: 1823260-2018-02763
• Device Sequence Number: 1536887
• Product Code: JLW
• UDI-Device Identifier: 04015630939831
• UDI-Public: 04015630939831
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K961491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07028091190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1